The primary objective of the study is to evaluate the pharmacokinetic behavior of Suc-HSA after consecutive daily intravenous (i.v.) doses. The secondary objectives are to evaluate the safety and tolerability and the antiretroviral and immunological effects of consecutive daily i.v. doses of Suc-HSA.

Further study details as provided by International Antiviral Therapy Evaluation Center:

Primary Outcome Measures:

To evaluate the pharmacokinetic behavior of Suc-HSA after consecutive daily i.v. doses.

Secondary Outcome Measures:

To evaluate the safety and tolerability and the antiretroviral and immunological effects of consecutive daily i.v. doses of Suc-HSA.

Estimated Enrollment:

6

Study Start Date:

August 2005

Study Completion Date:

June 2006

Detailed Description:

This is a single centre, single arm study. Subjects will receive 5 consecutive daily doses of Suc-HSA at a dose of 10 mg/kg on days 0, 1, 2, 3 and 4 on the Special Investigation Unit (SIU), with a safety follow up on the SIU for 4 hours on day 1 and 2 hours on the next days. There will be follow-up visits on week 1, 2, 4 and 12. Standard safety parameters (physical examination, clinical symptoms, laboratory hematology and biochemistry) will be followed until week 12. Plasma HIV-1 RNA and CD4+/CD8+ cell counts will be assessed at every visit. Plasma drug levels (trough and peak) will be measured from baseline until week 2.

6 patients will be included in this study as described in this protocol amendment.

Eligible subjects are chronic HIV-1 infected patients who have never been treated with antiretroviral treatment and for whom there is no need to start antiretroviral treatment.

Plasma HIV-1 RNA level at screening visit of at least 5.000 copies/ml, and not varying more than ± 0.5 log10 copies during the preceding 6 month period;

Patient was participant in part 1 of the original Suc-HSA study (protocol no. 2003-002, version 2.4, dated 18 November 2003) and the administration of Suc-HSA occurred more than 8 weeks ago, OR patient was not participant in this study;

Patient is one of the following:

not heterosexually active, OR

a heterosexually active female, agreeing to use an effective method of contraception with her partner (combined oral contraceptive pill; injectable contraceptive; intrauterine contraceptive device (IUCD); consistent use of condoms if using these; physiological or anatomical sterility in herself or her partner) from 14 days prior to the first administration of study medication until 4 months after the last, and willing to undergo urine pregnancy tests prior to the first and last administration, OR

a heterosexually active male, agreeing to use an effective method of contraception with his partner from the day of the first administration until 4 months after the last administration.

Exclusion Criteria:

History of an AIDS defining event;

Use of antiretroviral or immunomodulatory therapy;

Any reason to start antiretroviral therapy at the time of enrolment or which is expected to occur during the course of the study at the time of enrolment;

Presence of any clinically significant disease or findings during screening, that in the opinion of the investigator could compromise the safety of the subject;

Patient is female and (willing to become) pregnant or breast-feeding;

Any other condition which, in the opinion of the investigator, may interfere with the evaluation of the study objectives.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00128063